COVID-19 lgG/IgM Test (Test with Fluorescence Immunoassay Analyzer),COVID-19 Antibody Fluorescence Immunoass Test Range
Application:
The COVID-19 lgG/IgM Test is a Fluorescence Immunoassay qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in human whole blood, serum or plasma with the use of FIATEST Fluorescence Immunoassay Analyzer as an aid in the diagnosis of COVID-19 infection.
| Product Name: |
COVID-19 LgG/IgM Test (Test With Fluorescence Immunoassay Analyzer),COVID-19 Antibody Fluorescence Immunoass Test Range |
| Format: |
Cassette |
| Certificate: |
CE |
| Pack: |
10T/25T |
| Shelf Life: |
2 Years |
| Objective: |
Results Read By Analyzer |
| Principle: |
Fluorescence Immunoassay |
| Specimen: |
Nasopharyngeal Swab |
| Reading Time: |
10-15 Minutes |
| Storage Temperature: |
2-30℃ |
| Fast Result: |
10-15 Minutes |
| High Efficiency: |
Both STAT Testing And Batch Testing |
Description:
The IgE Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative, lateral flow immunoassay for the detection of human IgE antibody in whole blood, serum or plasma specimens. In this test, mouse anti-human IgE is coated in the test line region of the test. During testing, IgE present in whole blood, serum or plasma specimen reacts with mouse anti-human IgE coated particles in the test strip. The mixture then migrates forward on the membrane by capillary action and reacts with the mouse anti-IgE on the membrane in the test line region. The presence of a colored line in the test line region indicates a positive result for IgE, while its absence indicates a negative result for that infection.
To serve as a procedural control, a colored line will always appear in the control line region of the strip indicating that proper volume of specimen has been added and membrane wicking has occurred.
PRODUCT FEATURES
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【PERFORMANCE CHARACTERISTICS】
1. Accuracy
The test deviation is ≤±20%.
2. Assay Range and Detection Limit
Assay Range: 20 – 1600 IU/ml
Minimum Detection Limit (Analytical Sensitivity): 20 IU/ml
3. Linearity Range
20 – 800IU/ml, R≥0.990
4. Precision
Intra-lot precision C.V. is ≤ 15%
Inter-lot precision C.V. is ≤ 20%
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Fast Result (15 minutes)
Simple Operation (Less Training Required)
Objective (Results Read by Analyzer)
Stringent Quality Control Insure High Accuracy
User-friendly (Simple Plug & Play Operation)
High Efficiency (Both STAT Testing and Batch Testing)
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【INTERPRETATION OF RESULTS 】
(Please refer to the illustration above)
POSITIVE:* Two colored lines appear. One colored line should always appear in the control line region (C) and another line should be in the test line region.
*NOTE: The intensity of the color in the test line region may vary depending on the concentration of human IgE antibodies present in the specimen. Therefore, any shade of color in the test line region should be considered positive.
NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line region.
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
Product Tags:
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COVID-19 IgG IgM Rapid Test Cassette With Fluorescence Immunoassay Analyzer Images
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